Norepinephrine Bitartrate

For severe. ANDA 211359, held by Sandoz. Norepinephrine Bitartrate.

As of Nov 14, 2026, ANDA 211359 (Norepinephrine Bitartrate), held by Sandoz, was first approved by FDA on Oct 18, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 18, 2018
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine bitartrate injection is a catecholamine, indicated for restoration of blood pressure in adult patients with acute hypotensive states.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 18, 2018	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Norepinephrine BitartrateEQ 1MG BASE/ML · injectable;injection	Norepinephrine Bitartrate	Rx

All 2 submissions, including labeling and manufacturing supplements


Aug 12, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Oct 18, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 211359
Drugs@FDA: Overview at FDA
Company: Sandoz

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters